Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the “Surveillance”)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  A single-arm clinical surveillance study, Prospective non-randomized study

Study drug and medical condition

• Name of medicine, other:
  decellularized human aortic valve, Arise AV

Population studied

• Short description of the study population:
  Inclusion criteria: Indication for aortic valve replacement according to current medical guidelines. Signed Informed consent of legal guardians or patients, assent of patients. Exclusion criteria: The patient has not provided Surveillance informed consent. The patient shall not suffer fromgeneralized connective tissue disorders (e.g. Marfan syndrome), or active rheumatic disorders or severe asymmetric calcification of the valve ring. The coronary arteries of the patient shall not bein abnormal position or heavily calcified. Patients shall not showhypersensitivity against Sodium Dodecyl Sulphate, Sodium Desoxycholate, human collagen (or other elastic fibers) or Benzonase®.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  120

Study design details

• Main study objective:
  Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes within a prospective, non-randomized, single-arm, multi-centre surveillance study to be conducted in in 6 leading european sites and other qualified centres, which may be amended.
• Outcomes:
  Primary safety endpoints: Cardiovascular Adverse Reactions, e.g. all‐cause mortality, major stroke, life‐threatening bleeding, acute kidney injury, peri‐procedural myocardial infarction, major vascular complication, repeat procedure for valve‐related dysfunctionPrimary efficacy endpoint: Freedom from valve dysfunction leading to re-intervention or explantation at end of the study, Secondary safety endpoints: Blood Parameters as additional safety data to support presence/absence of Adverse Reactions, Time to reoperation, explantation and/or death.Secondary efficacy endpoint: Diameters of ARISE AV at end of the study in comparison to diameters at implantation, transvalvular gradients, valve competence assessed by noninvasive imaging tools
• Data analysis plan:
  Actuarial analysis according to Kaplan-Meier will be used to show estimated probability of freedom from each AR. Actuarial analysis takes into account both early and late post-operative events. The time from ARISE AV implantation to endpoint ARISE AV dysfunction that requires either a catheter-based or a surgical procedure will also be calculated according Kaplan and Meier.